The Food and Drug Administration removed an obstacle from of its “compassionate use” policy this month, eliminating some paperwork that physicians must do to obtain experimental drugs for some patients with immediately life-threatening illnesses.
Doctors will now file an application for FDA approval that contains just 11 questions, 15 fewer than the old form. They should be able to complete this new version in 45 minutes, the FDA said. The new form is simpler because it was designed for individual patients, replacing an all-purpose format that had been used by doctors acting on behalf of individuals or small or large groups of patients.
There had been concerns that doctors unfamiliar with how to submit the old form might have been deterred from applying for compassionate access, which is also known as expanded access, said FDA spokeswoman Sandy Walsh.
The policy is intended to help patients with incurable diseases who have tried all standard therapies and hope to extend their lives by taking experimental drugs not yet approved by the FDA, said Dr. Edward Kim, chair of the Department of Solid Tumor Oncology at the Carolinas HealthCare System’s Levine Cancer Institute.
The FDA’s old form was a “pretty laborious process,” Kim said. When doctors are serving patients whose time is precious, every minute saved on paperwork can help, he said.